Wrinkle
Conditions
Keywords
Microneedle patch, Anti-wrinkle
Brief summary
The core objective of this study is to validate the safe and efficacious application of the AcusMu microneedle patch (FMD WK) to enhance the appearance of periorbital wrinkle
Detailed description
This clinical study is a randomized, double-blind, split-face clinical trial investigating the efficacy of AcusMu (FMD WK) for the treatment of periorbital wrinkles. Participants will attend a study center for a two-week period and undergo a two-week post-treatment follow-up after their final treatment session. Each day, they will apply one of two test products: (A) micro-needle patches containing active anti-wrinkle ingredients and (B) placebo patches beneath their eyes. The patches will be gently pressed onto the skin for 5-10 seconds and left in place for 2-8 hours, continuing this regimen for 14 days. Dermatologists will conduct evaluations at four time points during the study: on day 0, day 7, day 14, and day 28 (±2 days) from the commencement of the experiment. The evaluation process will include the calculation of a Fine Wrinkle Improvement Index specifically designed for assessing under-eye wrinkles to measure improvements. Non-invasive skin testing equipment will be employed to measure skin conditions and capture skin images for objective data analysis (Wrinkle Index). Additionally, self-assessment questionnaires will be administered to gather insights into participants' perceptions of the efficacy of micro-needle patches with active anti-wrinkle ingredients and placebo patches in improving periorbital wrinkles over the two-week duration.
Interventions
DEVICEFMD WK
micro-needle patches containing active anti-wrinkle ingredients
Sponsors
Taipei Medical University Hospital
AcusMu Medtech Co., Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants aged 18 to 99 (regardless of race or gender). * Diagnosed with mild or moderate periorbital wrinkles by a dermatologist.
Exclusion criteria
* Participants with open wounds or active infections on their skin. * Individuals involved in other studies that could interfere with this trial. * Pregnant, breastfeeding, or planning to become pregnant during the trial. * Those with significant medical conditions such as cancer, liver disease, diabetes, kidney disease, or cardiovascular disorders. * Individuals who have undergone alternative treatments for periorbital wrinkles in the past six months (e.g., laser therapy, radiofrequency). * Participants concurrently receiving alternative treatments for periorbital wrinkles.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline | Over the course of study completion, an average duration of 4 weeks was observed. | 1. This is a half-face trial involving two weeks of treatment followed by a two-week post-treatment follow-up. 2. Improvements in periorbital wrinkles will be assessed using the Wrinkle Severity Rating Scale (WSRS), which ranges from 0 (no wrinkles) to 5 (severe wrinkles). A lower score indicates an improvement in wrinkle severity. 3. Each participant's treated half-face serves as the unit of measure. Any decrease in the WSRS score from baseline is counted as an improvement. |
| Number of Participants With Adverse Reactions | Over the course of study completion, an average duration of 4 weeks was observed. | Evaluate through skin response sheets: erythema, pain, swelling, etc. |
Countries
Taiwan
Participant flow
Recruitment details
A total of 12 subjects provided informed consent to participate in this study. Participants were assigned two different types of patches to be applied under the eyes (a split-face study), with one type on each arm: one randomly allocated active anti-wrinkle ingredient patch and one placebo patch. The 12 subjects underwent non-invasive skin testing equipment to record periorbital wrinkle conditions and completed self-assessment questionnaires during their study visit.
Participants by arm
| Arm | Count |
|---|---|
| FMD WK/Placebo (A Split-Face Study) We recruited 12 participants, each receiving a microneedle patch beneath one eye, randomly assigned to one side of the face. Each participant received both types of patches: one containing active anti-wrinkle ingredients and the other a placebo.
Microneedle patches are painless, require no training for application, and can be used with only video or image instructions. Each patch contains an array of solid, water-soluble, micron-scale needles that penetrate the skin's upper layers, dissolve in interstitial fluid, and release either the active anti-wrinkle ingredients or placebo. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | FMD WK/Placebo (A Split-Face Study) |
|---|---|
| Age, Continuous | 47.75 years STANDARD_DEVIATION 9.54 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Taiwan | 12 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Number of Participants With Adverse Reactions
Evaluate through skin response sheets: erythema, pain, swelling, etc.
Time frame: Over the course of study completion, an average duration of 4 weeks was observed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FMD WK | Number of Participants With Adverse Reactions | 0 Participants |
| Placebo | Number of Participants With Adverse Reactions | 0 Participants |
Primary
Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline
1. This is a half-face trial involving two weeks of treatment followed by a two-week post-treatment follow-up. 2. Improvements in periorbital wrinkles will be assessed using the Wrinkle Severity Rating Scale (WSRS), which ranges from 0 (no wrinkles) to 5 (severe wrinkles). A lower score indicates an improvement in wrinkle severity. 3. Each participant's treated half-face serves as the unit of measure. Any decrease in the WSRS score from baseline is counted as an improvement.
Time frame: Over the course of study completion, an average duration of 4 weeks was observed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FMD WK | Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline | Week 2 | 10 Participants |
| FMD WK | Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline | Week 4 | 8 Participants |
| Placebo | Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline | Week 2 | 2 Participants |
| Placebo | Proportion of Participants With Improvement in Periorbital Wrinkles From Baseline | Week 4 | 2 Participants |